Reduced Dose of Unfractionated Heparin in Patients Undergoing PCI (ISAR-REACT-3A)
This study has been completed.
Sponsor:
Deutsches Herzzentrum Muenchen
Information provided by (Responsible Party):
Deutsches Herzzentrum Muenchen
ClinicalTrials.gov Identifier:
NCT00735280
First received: August 12, 2008
Last updated: January 3, 2012
Last verified: January 2012
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Purpose
The aim of this trial is to evaluate whether a reduction in the heparin dose from 140 to 100 U/kg is associated with a better net clinical outcome in patients undergoing PCI after pretreatment with 600mg clopidogrel
| Condition | Intervention | Phase |
|---|---|---|
|
Coronary Artery Disease |
Drug: unfractionated heparin |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Non-randomized, Open-label, Historical Control, Single Group Assignment Trial of a Reduced Dose of Unfractionated Heparin in Patients Undergoing Percutaneous Coronary Interventions |
Resource links provided by NLM:
Further study details as provided by Deutsches Herzzentrum Muenchen:
Primary Outcome Measures:
- The primary outcome measure will be a composite of death, MI, urgent TVR after 30 days or in hospital bleeding (quadruple endpoint, "net clinical benefit"). [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Composite of death, MI or urgent TVR (Triple endpoint to assess ischemic complications) [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
- Composite of death, MI or TVR [ Time Frame: 1 year after the index procedure ] [ Designated as safety issue: Yes ]
| Enrollment: | 2505 |
| Study Start Date: | August 2008 |
| Study Completion Date: | March 2011 |
| Primary Completion Date: | March 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Reduced dose of unfractionated heparin |
Drug: unfractionated heparin
bolus of 100 U/kg of unfractionated heparin
|
Show Detailed Description
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Patients older than 18 years undergoing a PCI procedure
- Pretreatment with 600mg clopidogrel at least 2 hours before the intervention
- Informed, written consent by the patient or her/his legally-authorized representative for participation in the study.
Exclusion Criteria:
- Recent ST-elevation myocardial infarction within the last 48 hours
- Acute coronary syndromes with positive biomarkers (Troponin T > 0.03 μg/L or CK-MB > ULN)
- Cardiogenic shock
- Malignancies or other comorbid conditions (for example severe liver, renal and pancreatic disease) with life expectancy less than one year or that may result in protocol non-compliance
- Active bleeding; bleeding diathesis
- History of gastrointestinal or genitourinary bleeding within the last 6 weeks
- Presence of diseases which have a high probability of vascular lesions and subsequent bleeding such as active gastric ulcer or active ulcerous colitis
- Recent trauma or major surgery in the last month
- Ophthalmic surgery or brain surgery in the last month
- Retinopathies or vitreous body bleeding in the last month
- History of intracranial bleeding or structural abnormalities (for example aneurysm of cerebral arteries)
- Suspected aortic dissection; pericarditis and subacute bacterial endocarditis
- Patient's refusal to blood transfusion.
- Oral anticoagulation therapy with coumarin derivative within the last 7 days
- Treatment with UFH within 6 hours unless an ACT is less than 150 sec or low-molecular weight heparin within 8 hours before enrollment
- Treatment with bivalirudin within 24 hours before enrollment
- Severe uncontrolled hypertension >180/110 mmHg unresponsive to therapy
- Planned staged PCI procedure within 30 days from index procedure or prior PCI within the last 30 days.
- Relevant hematologic deviations: hemoglobin < 100 g/L, platelet count < 100 x 109 /L.
- Glomerular filtration rate (GFR) < 30 ml/min or serum creatinine > 30 mg/L or dependence on renal dialysis.
- Known allergy to the study medications: aspirin, clopidogrel, UFH, true anaphylaxis after prior exposure to contrast media.
- Known heparin-induced thrombocytopenia (Typ II)
- Previous enrollment in this trial.
- Pregnancy (present, suspected or planned) or positive pregnancy test.
- Spinal, peridural and epidural anesthesia
- Patient's inability to fully cooperate with the study protocol.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00735280
Locations
| Germany | |
| Herz-Zentrum | |
| Bad Krozingen, Germany, 79189 | |
| Deutsches Herzzentrum München | |
| München, Germany, 81541 | |
| Klinikum rechts der Isar der Technischen Universität München | |
| München, Germany, 81675 | |
Sponsors and Collaborators
Deutsches Herzzentrum Muenchen
Investigators
| Study Chair: | Adnan Kastrati, MD | Deutsches Herzzentrum München |
| Principal Investigator: | Julinda Mehilli, MD | Deutsches Herzzentrum München |
More Information
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Deutsches Herzzentrum Muenchen |
| ClinicalTrials.gov Identifier: | NCT00735280 History of Changes |
| Other Study ID Numbers: | GE IDE No. A01408 |
| Study First Received: | August 12, 2008 |
| Last Updated: | January 3, 2012 |
| Health Authority: | Germany: Ethics Commission |
Keywords provided by Deutsches Herzzentrum Muenchen:
|
Coronary artery disease, stent, heparin |
Additional relevant MeSH terms:
|
Coronary Artery Disease Myocardial Ischemia Coronary Disease Heart Diseases Cardiovascular Diseases Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases Calcium heparin |
Heparin Anticoagulants Hematologic Agents Therapeutic Uses Pharmacologic Actions Fibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action Cardiovascular Agents |
ClinicalTrials.gov processed this record on May 16, 2013